Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors

NCT06164145 | Recruiting

• 1 other identifier: HE662138
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are

1. 1.What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors?
2. 2.Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Short Form 36

  Short Form 36 (SF-36) is a generic self-reported outcome measure that quantifies the quality of life in relation to health status. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. The scores range from 0-100 (the worst possible to the most possible) (Ware \& Sherbourne, 1992).

  Baseline-1 week-4th week

Secondary Outcomes (4)

• Patient Reported Outcome Measurement System (PROMIS-29)

  Baseline-1 week

• Berg Balance Scale (BBS)

  Baseline-1 week

• Barthel Index (BI)

  Baseline-1 week

• Global Rating of Change (GRC) Scale

  Baseline-1 week-4th week

Study Arms (1)

patients with hemiplegia

The intervention program will be based on usual care physiotherapy treatment in a hospital setting. It will be given 3 times per day, 5 days per week for 4 weeks duration.

Other: Usual care

Interventions

Usual care OTHER

The training program used in this study is the stroke rehabilitation program focusing on health education for stroke and a routine exercise program based on the National Strategic Plan for Stroke Rehabilitation in Myanmar.

patients with hemiplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemiplegic patients who will be treated at inpatient ward of Department of Physical Medicine and Rehabilitation

You may qualify if:

• Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
• Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi \& Hamzat, 2014)
• Ability to understand the study and respond to questions (on the Mini- Mental State Examination \> 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
• Stable medical conditions

You may not qualify if:

• Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
• Recurrent stroke
• Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)
• \) Participants who cannot understand Burmese language

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Yangon General Hospital

Yangon, 11131, Burma

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Myitzu Khin Khin, Master

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myitzu Khin Khin, Master

CONTACT

+959254219894; myitzu.k@kkumail.com

Sawitri Wanpen, PhD

CONTACT

+66951691352; sawitri@kku.ac.th

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after publication

Locations

BU (1)